ABX PENTRA DF 120

GUDID 03610230005965

ABX PENTRA DF 120 (110V), ABX PENTRA DF 120 (220V)

HORIBA ABX SAS

Haematological cell analyser IVD, automated Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD

• Primary Device ID: 03610230005965
• NIH Device Record Key: 0da94ef9-83d5-4841-a888-de54df4fded6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABX PENTRA DF 120
• Version Model Number: 1280100045, 1280100059
• Company DUNS: 273647420
• Company Name: HORIBA ABX SAS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610230005965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050719

FDA Product Code

• GKZ: Counter, Differential Cell

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-09-02

On-Brand Devices [ABX PENTRA DF 120]

• 03610230006290: 100 or 110V, ready for SPS
• 03610230006283: ABX PENTRA DF 120 (110V), ABX PENTRA DF 120 (100V)
• 03610230005965: ABX PENTRA DF 120 (110V), ABX PENTRA DF 120 (220V)